Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (SPICE III Trial) [2014] NSWCATGD 44

NSW Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (SPICE III Trial) [2014] NSWCATGD 44 Hearing dates: 17 December 2013, 8 May 2014, 15 October 2014 Date of orders: 23 December 2014 Decision date: 23 December 2014 Jurisdiction: Guardianship Division Before: Fougere C, Principal Member West C, Senior Member (Professional) Porter L, General Member (Community) Decision: The SPICE III Trial approved as a clinical trial in which adults who are unable to consent may participate. Function of giving or withholding consent to be exercised by the Tribunal. Catchwords: CLINICAL TRIAL – comparison of standard care sedation strategies in intensive care units – randomisation of treatment - use of dexmedetomidine beyond TGA authority - whether a clinical trial - Clinical Trial Notification Scheme under Therapeutic Goods Act 1989 – 'delayed consent' not part of Guardianship Act. Legislation Cited: Civil and Administrative Tribunal Act 2013 (NSW) Guardianship Act 1987 (NSW) National Health and Medical Research Council Act 1992 Therapeutic Goods Act 1989 (Cth) Therapeutic Goods Regulations 1990 (Cth) Australian Code for the Responsible Conduct of Research (2007) Cases Cited: Alcan (NT) Alumina Pty Ltd v Commissioner of Territory Revenue [2009] HCA 41; (2009) 239 CLR 27, Hayne, Heydon, Crennan, Kiefel JJ, [47] Commissioner of Taxation v Consolidated Media Holdings Ltd (2012) 293 ALR 257; [2012] HCA 55, French CJ, Hayne, Crennan, Bell and Gageler JJ, [39] Amalgamated Society of Engineers v Adelaide Steamship Co Ltd (192) 28 CLR 129, 161-162 (Higgins J) Project Blue Sky Inc v Australian Broadcasting Authority (1998) 194 CLR 355, McHugh, Gummow, Kirby and Hayne JJ, 384 [78] Texts Cited: Pearce and Geddes Statutory Interpretation in Australia, 8th Edition, (2014) LexisNexis Butterworths Online [3.30] The Macquarie Dictionary (online edition) The Oxford English Dictionary (online edition) National Health and Medical Research Council, "National Statement on Ethical Conduct in Human Research" 2007 (Updated March 2014) https://www.nhmrc.gov.au/book/national-statement-ethical-conduct-human-research accessed 23 December 2014 Category: Principal judgment Parties: Dr Yahya Shehabi (Applicant) File Number(s): 10/2013 Publication restriction: Nil